67 FR 15 pgs. 3113-3118 - Mepiquat; Pesticide Tolerance
Type: RULEVolume: 67Number: 15Pages: 3113 - 3118
Docket number: [OPP-301209; FRL-6818-7]
FR document: [FR Doc. 02-1618 Filed 1-22-02; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301209; FRL-6818-7]
RIN 2070-AB78
Mepiquat; Pesticide Tolerance
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes a tolerance for residues ofmepiquat (N,N-dimethylpiperidinium) in or on cottonseed at 2.0 parts per million (ppm);cotton, gin byproducts at 6.0 ppm; and meat byproducts of cattle, goat, hog, horse andsheep at 0.1 ppm. BASF Corporation requested these tolerances under the Federal Food, Drug,and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES:
This regulation is effective January 23, 2002. Objections and requests for hearings, identified by docket control number OPP-301209, must be received by EPA on or before March 25, 2002.
ADDRESSES:
Written objections and hearing requests may be submittedby mail, in person, or by courier. Please follow the detailed instructions for each method asprovided in Unit VI. of the SUPPLEMENTARY INFORMATION . To ensureproper receipt by EPA, your objections and hearing requests must identify docket controlnumberOPP-301209 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT:
By mail: DennisMcNeilly, Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number:(703) 308-6742; e-mail address: mcneilly.dennis@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural producer, foodmanufacturer, or pesticide manufacturer. Potentially affected categories and entities mayinclude,but are not limited to:
| Categories | NAICS codes | Examples of potentially affected entities |
|---|---|---|
| Industry | 111 | Crop production |
| 112 | Animal production | |
| 311 | Food manufacturing | |
| 32532 | Pesticide manufacturing |
This listing is not intended to be exhaustive, but rather provides a guide for readersregarding entities likely to be affected by this action. Other types of entities not listed in thetablecould also be affected. The North American Industrial Classification System (NAICS) codeshave been provided to assist you and others in determining whether or not this action mightapplyto certain entities. If you have questions regarding the applicability of this action to a particularentity, consult the person listed under FOR FURTHER INFORMATIONCONTACT .
B. How Can I Get Additional Information, Including Copies of this Document and OtherRelated Documents?
1. Electronically . You may obtain electronic copies of thisdocument, and certain other related documents that might be available electronically, from theEPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Pageselect "Laws and Regulations," "Regulations and Proposed Rules,"and then look up the entry for this document under the " FederalRegister -Environmental Documents." You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/ . A frequently updatedelectronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development. To access the OPPTSHarmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person . The Agency has established an official record for thisaction under docket control number OPP-301209. The official record consists of thedocuments specifically referenced in this action, and other information related to this action,including any information claimed as Confidential Business Information (CBI). This officialrecord includes the documents that are physically located in the docket, as well as the documentsthat are referenced in those documents. The public version of the official record does notincludeany information claimed as CBI. The public version of the official record, which includesprinted, paper versions of any electronic comments submitted during an applicable commentperiod is available for inspection in the Public Information and Records Integrity Branch(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone numberis(703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 15, 2001 (66 FR 57446)(FRL-6809-6), EPA issued a notice pursuant to section 408 of the Federal Food,Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality ProtectionAct of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition(PP) for tolerance by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC27709-3528. This notice included a summary of the petition prepared by BASFCorporation, the registrant. There were no comments received in response to the notice offiling.
The petition requested that 40 CFR 180.384 be amended by establishing a tolerancefor residues of the plant growth regulator mepiquat, N,N-dimethylpiperidinium chlorideand N,N-dimethylpiperidinium pentaborate, in or on cottonseed at 2.0 ppm; cotton, ginbyproducts at 6.0 ppm; and meat byproducts of cattle, goat, hog, horse, and sheep at 0.1ppm.
The Agency is making the following minor changes to the tolerance actionproposed in the petition:
1. The title for the tolerance (§ 180.384) will be revised to mepiquat(N,N-dimethylpiperidinium) to reflect the fact that the tolerance covers both the "chloridesalt" (mepiquat chloride) and "pentaborate salt" (mepiquatpentaborate) forms of mepiquat.
2. Paragraph (a) is divided into two paragraphs with paragraph (a)(1) reflecting the"generic " tolerance for residues of either the "chloride salt," or"pentaborate salt," or both (e.g., cotton); while paragraph (a)(2) reflects thosetolerances established only for the "chloride salt " form of mepiquat, i.e.,mepiquat chloride. It is possible that in the future the Agency may propose combiningthese two paragraphs; however, mepiquat pentaborate is currently only proposed forregistration on cotton. The only new commodity in this document for both mepiquatchloride and mepiquat pentaborate is cotton gin byproducts. The Mepiquat Chloride RED(March 1997) required residue data for this commodity, it has now been reviewed and theAgency has determined that a separate tolerance is required for this commodity. Thisresulted because of a revision to the Pesticide Assessment Guideline (Subdivision O,Residue Chemistry, 9/95) which recognized cotton gin byproducts as a raw agriculturalcommodity of cotton.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legallimit for a pesticide chemical residue in or on a food) only if EPA determines that the toleranceis"safe." Section 408(b)(2)(A)(ii) defines "safe" to mean that"there is a reasonable certainty that no harm will result from aggregate exposure to the pesticidechemical residue, including all anticipated dietary exposures and all other exposures for whichthere is reliable information." This includes exposure through drinking water and inresidential settings, but does not include occupational exposure. Section 408(b)(2)(C) requiresEPA to give special consideration to exposure of infants and children to the pesticide chemicalresidue in establishing a tolerance and to "ensure that there is a reasonable certainty thatnoharm will result to infants and children from aggregate exposure to the pesticide chemicalresidue...."
EPA performs a number of analyses to determine the risks from aggregate exposure topesticide residues. For further discussion of the regulatory requirements of section 408 and acomplete description of the risk assessment process, see the final rule on Bifenthrin PesticideTolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
A human health risk assessment was previously conducted for mepiquat chloridefoliar use on cotton and was published in the Mepiquat Chloride RED, March 1997. In fact,tolerances have been established for mepiquat chloride in/on cottonseed at 2.0 ppm and animalcommodities at 0.1 ppm. In addition, the Agency recently published a risk assessment (65 FR1790, January 12, 2000) (FRL-6485-4) for mepiquat chloride use on grapes andraisins which included the previously registered use on cotton. The January 12, 2000, riskassessment reflects the most current risk assessment available for mepiquat and will be referredtothroughout this document. A revised risk and exposure analysis for use of mepiquat pentaborate,a "pentaborate salt" of mepiquat being registered for foliar use on cotton, was notconducted because exposure to mepiquat chloride from use on cotton was evaluated in theAgency's January 12, 2000, risk assessment. The registrant was required to submit a completebattery of acute toxicity studies, product chemistry data and a dissociation study to verify thatmepiquat pentaborate application would be toxicologically equivalent to mepiquat chlorideapplication and that the impurities would remain essentially equivalent or improved (moreprotective of human/ecological health) over current mepiquat chloride products. The companymaintains, and the Agency has verified that both compounds, the "chloride salt"version mepiquat chloride and the "pentaborate salt" version mepiquatpentaborate,disassociate in water in the same manner and result in the same exposure, both qualitatively andquantitatively. Use rates and other label restrictions, related to food residue levels and toleranceissues, will be the same as for current mepiquat chloride products. Review of the productchemistry data confirmed that no new toxicologically significant impurities would be involved.Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and otherrelevant information in support of this action. EPA has sufficient data to assess the hazards ofandto make a determination on aggregate exposure, consistent with section 408(b)(2), for atolerancefor residues of mepiquat on cottonseed at 2.0 ppm; cotton, gin byproducts at 6.0 ppm; andmeat byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm. EPA's assessment ofexposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
The Agency has determined that mepiquat pentaborate and mepiquat chloride are notsignificantly different as to impurities and/or toxicologically significant moieties. The registranthas submitted a battery of acute toxicity studies for mepiquat pentaborate which demonstrate thatthe acute toxicity is not significantly different from that of mepiquat chloride. The registrant hasalso submitted a dissociation study that demonstrates that mepiquat pentaborate dissociates inwater in an identical physical manner to mepiquat chloride. It is the Agency's general policy thattoxicology data for one "salt" support other mineral salts and that no additionaltoxicological data would be required for those entities. Mepiquat chloride is already registered for use on cotton and tolerances are established in40 CFR 180.384 for residues of mepiquat chloride in/on cottonseed. In addition, tolerances formepiquat chloride already exist for the fat, meat, and meat byproducts of cattle, goats, hogs,horses, and sheep (each at 0.1 ppm). The acute toxicity data for technical grade mepiquat pentaborate indicate toxicity categoryIII for acute oral toxicity, acute dermal, acute inhalation, and primary eye irritation. Theprimarydermal irritation for mepiquat pentaborate is category IV, and mepiquat pentaborate is not a skinsensitizer.
B. Toxicological Endpoints
The Agency has determined that mepiquat pentaborate and mepiquat chloride are notsignificantly different as to impurities and/or toxicological significant moieties. Therefore, thetoxicological endpoints published for mepiquat chloride on January 12, 2000 (65 FR 1790),pertain to this revision to 40 CFR 180.384. This revision to 40 CFR180.384 simply adds tolerances for the pentaborate "salt" of mepiquat to theexisting tolerances for the chloride "salt" version of mepiquat.
The Acute Population Adjusted Dose (aPAD) is 0.6 milligrams/kilograms/day (mg/kg/day)based on a 1-year dog feedingstudy with a 90-day dog feeding study supporting the 1-year dog study. The no observedadverse effect level (NOAEL) was 58.4 mg/kg/day with an Uncertainty Factorof 100 and the FQPA safety factor reduced to 1X. The Chronic Population Adjusted Dose(cPAD) is 0.6 mg/kg/day based on the 1-year dog feeding study with a supporting 90-day dogfeeding study. The NOAEL was 58.4 mg/kg/day with an Uncertainty Factor of 100 and theFQPAsafety factor reduced to 1X. Mepiquat chloride is classified as "not likely" to be ahuman carcinogen.
C. Exposure Assessment
1. Dietary exposure from food and feed uses . Tolerances have beenestablished (40 CFR 180.384) for the residues of mepiquat, in or on a variety of raw agriculturalcommodities. Tolerances are established for cottonseed and for the fat, meat, and meatbyproducts of cattle, goats, hogs, horses, and sheep at 0.1 ppm. A risk assessment wasconducted by EPA and published for mepiquat chloride on January 12, 2000, that discusses useoncotton as well as all other registered uses of mepiquat chloride. Dietary exposure from the useofmepiquat pentaborate on cotton will be qualitatively and quantitatively the same as for theexisting use of mepiquat chloride on cotton. The Agency has a disassociation study thatconfirmsthe qualitative equivalence and the same use rates and other restrictions will ensure equivalentquantitative exposure. The company expects that the pentaborate salt formulation of mepiquat,mepiquat pentaborate, will replace a significant amount of mepiquat chloride use on cotton.
i. Acute exposure . The acute dietary food exposures (95th percentile) occupy only 1.5% of the aPAD for the most highly exposed subgroup (children1-6 years). This is based on a Tier 1 analysis, assuming tolerance level residues and100% crop treated. Percent crop treated and/or anticipated residues were not used in theJanuary 12, 2000, analysis.
ii. Chronic exposure . The chronic dietary food exposures occupy only0.3% of the cPAD for the most highly exposed subgroup (children 1-6 years). This isbased on a Tier 1 analysis, assuming tolerance level residues and 100% crop treated.Percent crop treated and/or anticipated residues were or were not used in the January 12,2000, analysis.
iii. Cancer . Mepiquat chloride was classified as "not a likelyhuman carcinogen." Therefore, a cancer risk assessment was not conducted for thisrisk analysis; nor, was one conducted for the January 12, 2000, risk analysis that discussedthe use on cotton as well as all other mepiquat uses.
2. Dietary exposure from drinking water . The Agency published arisk assessment for mepiquat chloride on January 12, 2000, that discusses use on cotton as wellasall other registered uses of mepiquat chloride. In that analysis risk estimates for exposure tomepiquat chloride were below the Agency's level of concern. The Agency has reviewed adissociation study for mepiquat pentaborate that demonstrates that mepiquat pentaboratedissociates in an identical physical manner to mepiquat chloride in water. Therefore, theanalysisperformed for mepiquat chloride or the "chloride salt," also pertains to thismepiquat "pentaborate salt" use because the use rate, maximum seasonal use rateand other pertinent use factors remain the same as for mepiquat chloride or the "chloridesalt."
3. From non-dietary exposure . The term "residentialexposure" is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick controlon pets). Mepiquat chloride and/or mepiquat pentaborate are not registered for use on anysites that would result in residential exposure.
4. Cumulative exposure to substances with a common mechanism oftoxicity . Section 408(b)(2)(D)(v) requires that, when considering whether to establish,modify, or revoke a tolerance, the Agency consider "available information"concerning the cumulative effects of a particular pesticide's residues and "othersubstancesthat have a common mechanism of toxicity."
EPA does not have, at this time, available data to determine whether mepiquatpentaborate and/or mepiquat chloride have a common mechanism of toxicity with othersubstances or how to include this pesticide in a cumulative risk assessment. Unlike otherpesticides for which EPA has followed a cumulative risk approach based on a commonmechanism of toxicity, mepiquat does not appear to produce a toxic metabolite produced byothersubstances. For the purposes of this tolerance action, therefore, EPA has not assumed thatmepiquat has a common mechanism of toxicity with other substances. For information regardingEPA's efforts to determine which chemicals have a common mechanism of toxicity and toevaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin PesticideTolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
In general . FFDCA section 408 provides that EPA shall apply anadditional tenfold margin ofsafety for infants and children in the case of threshold effects to account for prenatal andpostnataltoxicity and the completeness of the data base on toxicity and exposure unless EPA determinesthat a different margin of safety will be safe for infants and children. Margins of safety areincorporated into EPA risk assessments either directly through use of a margin of exposure(MOE) analysis or through using uncertainty (safety) factors in calculating a dose level thatposesno appreciable risk to humans.
The Agency has determined that the FQPA safety factor for mepiquat is 1X. Seethe Agency's risk assessment for mepiquat chloride dated January 12, 2000, for details. Thefacts are that mepiquat pentaborate is another "salt" of mepiquat and thatmepiquat pentaborate disassociates to mepiquat and therefore the basic toxicology database for mepiquat chloride pertains to mepiquat pentaborate.
E. Aggregate Risks and Determination of Safety
1. Acute risk . The Agency concludes that residues of mepiquat infood and drinking water will not exceed the Agency's level of concern (100% of the aPAD).For details see the Agency risk assessment published on January 12, 2000.
2. Chronic risk . The Agency concludes that residues of mepiquatin food and drinking water will not exceed the Agency's level of concern (100% of thecPAD). For details see the Agency's risk assessment published on January 12, 2000.
3. Short-term risk . Short-term aggregate exposure takes into accountresidential exposure plus chronic exposure to food and water (considered to be a backgroundexposure level). Mepiquat chloride and mepiquat pentaborate are not registered for use on anysites that would result in residential exposure. Therefore, the aggregate risk is the sum of theriskfrom food and water, which do not exceed the Agency's level of concern.
4. Intermediate-term risk . Intermediate-term aggregate exposure takesinto account residential exposure plus chronic exposure to food and water (considered to be abackground exposure level). Mepiquat chloride and mepiquat pentaborate are not registered foruse on any sites that would result in residential exposure. Therefore, the aggregate risk is thesumof the risk from food and water, which does not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population . Mepiquat chloride isclassified as a "not likely" human carcinogen and thus not expected to pose acancer risk to humans.
6. Determination of safety . Based on these risk assessments, EPAconcludes that there is a reasonable certainty that no harm will result to the general population,andto infants and children from aggregate exposure to mepiquat residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the tolerance expression.The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of PesticidePrograms, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian, or Mexican tolerances established for mepiquat oncotton. Thus, there are no international harmonization issues for these tolerances.
C. Conditions
The Agency is requiring as conditions for registration the following:
1. Side-by-side residue field trials conducted with water as the diluent in all cottongrowing areas of the United States (minimum of three).
2. Developmental neurotoxicity study for mepiquat pentaborate.
V. Conclusion
Therefore, the tolerance expression in 40 CFR 108.384(a)(1) is revised to reflect residuesof mepiquat, in or on cottonseed; cotton gin by-products; and meatbyproducts of cattle, goat, hog, horse, and sheep at 2.0, 6.0, and 0.1 ppm, respectively.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file anobjection to any aspect of this regulation and may also request a hearing on those objections.TheEPA procedural regulations which govern the submission of objections and requests for hearingsappear in 40 CFR part 178. Although the procedures in those regulations require somemodification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA willcontinue to use those procedures, with appropriate adjustments, until the necessary modificationscan be made. The new section 408(g) provides essentially the same process for persons to"object" to a regulation for an exemption from the requirement of a toleranceissuedby EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409.However, the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance withthe instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA,you must identify docket control number OPP-301209 in the subject line on the firstpageof your submission. All requests must be in writing, and must be mailed or delivered to theHearing Clerk on or before March 25, 2002.
1. Filing the request . Your objection must specify the specificprovisions in the regulation that you object to, and the grounds for the objections (40 CFR178.25).If a hearing is requested, the objections must include a statement of the factual issues(s) onwhich ahearing is requested, the requestor's contentions on such issues, and a summary of any evidencerelied upon by the objector (40 CFR 178.27). Information submitted in connection with anobjection or hearing request may be claimed confidential by marking any part or all of thatinformation as CBI. Information so marked will not be disclosed except in accordance withprocedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI mustbe submitted for inclusion in the public record. Information not marked confidential may bedisclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may alsodeliveryour request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Mondaythrough Friday, excluding legal holidays. The telephone number for the Office of the HearingClerk is (202) 260-4865.
2. Tolerance fee payment . If you file an objection or request ahearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of thatfeepursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters AccountingOperations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251.Please identify the fee submission by labeling it "Tolerance Petition Fees."
EPA is authorized to waive any fee requirement "when in the judgement of theAdministrator such a waiver or refund is equitable and not contrary to the purpose of thissubsection." For additional information regarding the waiver of these fees, you maycontactJames Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or bymailing a request for information to Mr. Tompkins at Registration Division (7505C), Office ofPesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mailyour request for such a waiver to: James Hollins, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460.
3. Copies for the Docket . In addition to filing an objection or hearingrequest with the Hearing Clerk as described in Unit VI.A., you should also send a copy of yourrequest to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mailyour copies, identified by docket control number OPP-301209, to: Public InformationandRecords Integrity Branch, Information Resources and Services Division (7502C), Office ofPesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIBdescribed in Unit I.B.2. You may also send an electronic copy of your request via e-mail to:opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special charactersandany form of encryption. Copies of electronic objections and hearing requests will also beacceptedon disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electroniccopy. You may also submit an electronic copy of your request at many Federal DepositoryLibraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the materialsubmitted shows the following: There is a genuine and substantial issue of fact; there is areasonable possibility that available evidence identified by the requestor would, if establishedresolve one or more of such issues in favor of the requestor, taking into account uncontestedclaimsor facts to the contrary; and resolution of the factual issues(s) in the manner sought by therequestorwould be adequate to justify the action requested (40 CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d) in response to apetition submitted to the Agency. The Office of Management and Budget (OMB) has exemptedthese types of actions from review under Executive Order 12866, entitled RegulatoryPlanning and Review (58 FR 51735, October 4, 1993). Because this rule has been exemptedfrom review under Executive Order 12866 due to its lack of significance, this rule is not subjecttoExecutive Order 13211, Actions Concerning Regulations That Significantly AffectEnergy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule doesnotcontain any information collections subject to OMB approval under the Paperwork ReductionAct(PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain anyunfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995(UMRA) (Public Law 104-4). Nor does it require any special considerations underExecutive Order 12898, entitled Federal Actions to Address Environmental Justice inMinority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); orOMB review or any Agency action under Executive Order 13045, entitled ProtectionofChildren from Environmental Health Risks and Safety Risks (62 FR 19885, April 23,1997).This action does not involve any technical standards that would require Agency consideration ofvoluntary consensus standards pursuant to section 12(d) of the National Technology TransferandAdvancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272note). Since tolerances and exemptions that are established on the basis of a petition underFFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of aproposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action willnothave a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure"meaningful and timely input by State and local officials in thedevelopment ofregulatory policies that have federalism implications." "Policies that havefederalism implications" is defined in the Executive Order to include regulations thathave"substantial direct effects on the States, on the relationship between the nationalgovernment and the States, or on the distribution of power and responsibilities among thevariouslevels of government." This final rule directly regulates growers, food processors, foodhandlers and food retailers, not States. This action does not alter the relationships or distributionofpower and responsibilities established by Congress in the preemption provisions of FFDCAsection408(n)(4). For these same reasons, the Agency has determined that this rule does not have any"tribal implications" as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249,November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process toensure "meaningful and timely input by tribal officials in the development of regulatorypolicies that have tribal implications." "Policies that have tribalimplications" is defined in the Executive Order to include regulations that have"substantial direct effects on one or more Indian tribes, on the relationship between theFederal government and the Indian tribes, or on the distribution of power and responsibilitiesbetween the Federal government and Indian tribes." This rule will not have substantialdirect effects on tribal governments, on the relationship between the Federal government andIndian tribes, or on the distribution of power and responsibilities between the Federalgovernmentand Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does notapply to this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by theSmall Business Regulatory Enforcement Fairness Act of 1996, generally provides that before arulemay take effect, the agency promulgating the rule must submit a rule report, which includes acopyof the rule, to each House of the Congress and to the Comptroller General of the United States.EPA will submit a report containing this rule and other required information to the U.S. Senate,theU.S. House of Representatives, and the Comptroller General of the United States prior topublication of this final rule in the Federal Register . This final rule is not a"major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agriculturalcommodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: January 4, 2002.
Richard P. Keigwin, Jr.,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority:
21 U.S.C. 321(q), 346(a) and 374.
2. Section 180.384 is revised to read as follows:
§ 180.384 Mepiquat(N,N-dimethylpiperidinium); tolerances for residues.
(a) General . (1) Tolerances are established for residues of the plant growthregulator mepiquat (N,N-dimethylpiperidinium) in or on the following commodities:
| Commodity | Parts per million |
|---|---|
| Cattle, mbyp | 0.1 |
| Cotton, gin by-products | 6.0 |
| Cottonseed | 2.0 |
| Goats, mbyp | 0.1 |
| Hogs, mbyp | 0.1 |
| Horses, mbyp | 0.1 |
| Sheep, mbyp | 0.1 |
(2) Tolerances are established for residues of the plant growth regulator mepiquatchloride (N,N-dimethylpiperidinium chloride) in or on the following commodities:
| Commodity | Parts per million |
|---|---|
| Cattle, fat | 0.1 |
| Cattle, meat | 0.1 |
| Goat, fat | 0.1 |
| Goat, meat | 0.1 |
| Grapes | 1.0 |
| Hogs, fat | 0.1 |
| Hogs, meat | 0.1 |
| Horses, fat | 0.1 |
| Horses, meat | 0.1 |
| Raisins | 5.0 |
| Sheep, fat | 0.1 |
| Sheep, meat | 0.1 |
(b) Section 18 emergency exemptions . [Reserved]
(c) Tolerances with regional registrations . [Reserved]
(d) Indirect or inadvertent residues . [Reserved]
[FR Doc. 02-1618 Filed 1-22-02; 8:45 am]
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